Identity
- Trade Name
- AccuTab FDA UDI
- Generic Name
- Multi-parameter urinary monitoring system control unit FDA UDI
- Device Name
- AccuTab is a tablet with associated software (AccuData) that connects to the Accuryn Monitor. The tablet is an extension of the Accuryn Monitor and only displays the data that already exists on the Accuryn Monitor. AccuTab with AccuData is solely intended to transfer, store, convert forms, and display medical device data from the Accuryn Monitor. FDA UDI
- Model / Reference
- FGN-06-101581 FDA UDI
- Description
- AccuTab is a tablet with associated software (AccuData) that connects to the Accuryn Monitor. The tablet is an extension of the Accuryn Monitor and only displays the data that already exists on the Accuryn Monitor. AccuTab with AccuData is solely intended to transfer, store, convert forms, and display medical device data from the Accuryn Monitor. FDA UDI
Identifiers
- Catalog Number
- FGN-06-101581 FDA UDI
- Primary DI / UDI-DI
- 00850019755015 FDA UDI
- 510(k) Number
- K221020 FDA UDI
- FDA Product Code
- OUG FDA UDI
- GMDN Term
- Multi-parameter urinary monitoring system control unit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6310 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Multi-parameter urinary monitoring system control unit
AccuTab by Potrero Medical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Potrero Medical, Inc.
Sources (1)
- FDA UDI 54cfce24-3106-42a1-a2a0-ae02313e813d 36 fields · synced Jun 8, 2026